- State of Massachusetts (Boston, MA)
- …**Compliance and Certification* **Organization:** **Department of Workforce Development* **Title:** * Ind . Accident Investigator I* **Location:** ... needs of employers to certain workers' compensation insurance costs. The Investigator I investigates suspected or alleged violations regarding Workers' Compensation… more
- Kelly Services (Seattle, WA)
- …reviews labeling, biological product deviation reporting, lot distribution reports, IND safety reports, clinical/ investigator documentation, or other reports, ... will assist in the development and execution of CMC regulatory strategies, regulatory submissions ( IND , BLA, NDA) in the area of Human Gene and Cell Therapies and/or… more
- Actalent (Hackensack, NJ)
- …review, preparation, and submission of clinical study documentation (eg, investigator brochure, Investigational Device Exemption (IDE), Investigational New Drug ( ... IND ), treatment, and compassionate/emergent use). + Ensure the timely...timely and accurate submission of all protocol amendments, ICF, Investigator Brochure, and other administrative items to the IRB… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …The incumbent will lead the successful delivery of early-stage clinical milestones such as Pre- IND , phase 1 and phase 2A for the company, drawing on expertise in ... clinical programs: SAE assessment, queries and follow-up, annual reports and investigator brochures. + Collaborates with, communicates with, and as required oversees… more
- ThermoFisher Scientific (Wilmington, NC)
- …and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators ... writing (interpretation of safety and efficacy data) and/or review of CSR, IND /NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …+ Collaborates with Regulatory Affairs to provide all documents required for IND , CT or other Regulatory submissions. + Generates Clinical Supply Specification and ... up, user acceptance testing and on-going management. + Reviews and approves Investigator site storage & dispensing activities. + Manages activities related to IMP… more
- Actalent (Richmond, VA)
- …priorities are essential. The team runs Phase I-III and sometimes IV trials, including investigator -initiated trials where they hold the IND as investigator ... position is $26.00 - $38.00 * Medical, dental & vision* Critical Illness, Accident , and Hospital* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …including the preparation/review of related key documents (ie protocols, Investigator 's Brochures, clinical study reports, summaries for regulatory submissions). The ... study implementation and successful completion + Makes presentations at the Investigator Meetings and other relevant internal or external venues + Responsible… more